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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameJUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Supplement NumberS030
Date Received12/26/2012
Decision Date03/11/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf-life from 18 months to 20 months for the 1ml syringe; an increase in the onoethylglycinexylidide (megx) impurity specification from 2. 5% to 3. 5% w/w of the label strength and total impurities from 3. 0% to 4. 3% of label strength.
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